# K120983: Ultraflex Esophageal NG Stent System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: May 2, 2012 after 30 days
- Product code: ESW (Prosthesis, Esophageal)
- Device class: 2
- Regulation: 21 CFR 878.3610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K955347 (1996). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091816: Ultraflex Esophageal NG Stent System, Boston Scientific Corporation (2009) Summary page 1.

## Most influential descendants
- K130004: Ultraflex Esophageal NG Stent System (2013), 2 descendants of its own
- K233939: Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (2024), 1 descendant of its own
- K261978: WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System (2026), 0 descendants of its own

## Indications for use
Ultraflex™ Esophageal NG Stent System (covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only, and occlusion of concurrent esophageal fistula.

Source page: https://510kreport.com/device/K120983
Methodology: https://510kreport.com/methodology